Class 2 Device Recall CytoChex BCT

• Date Initiated by Firm: February 23, 2017
• Date Posted: March 08, 2017
• Recall Status: Open, Classified
• Recall Number: Z-1684-2017
• Recall Event ID: 76501
• 510(K)Number: K080552
• Product Classification: Tubes, vacuum sample, with anticoagulant - Product Code GIM
• Product: Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0ml only. Packaged 6-tube pack REF 213559 and 100-tube box REF 218980. Streck.
• Code Information: UDI Number 10844509000836 and 20844509000833. Lot(s) Expiration Date 50910309 04-01-2017 60760309 03-16-2018 61460309 05-25-2018
• FEI Number: 1950302
• Recalling Firm/ Manufacturer: Streck; 7002 S 109th St; La Vista NE 68128-5729
• For Additional Information Contact: Maria J. Dosseh; 402-333-1982
• Manufacturer Reason for Recall: Complaints of the 2.0ml tube stopper coming loose during phlebotomy when small diameter tube adapters were not utilized. Such adapters aid with centering small diameter tubes to properly pierce the middle of the stoppers.
• FDA Determined Cause: Error in labeling
• Action: On February 23, 2017, Streck electronically notified customers of the updated device correction. The recalling firm used an electronic mail alert to notify all of their customers the IFU for the recalled product had been revised. The specified the revision included phlebotomy guidelines specific to the 2.0 ml blood collections tubes. The revised IFU was provided as a link in the email. The recalling firm is reportedly able to monitor the access of the revised IFU to ensure each customer has received the information. For further questions, please call (402) 333-1982.
• Quantity in Commerce: 128,692 tubes
• Distribution: Worldwide Distribution - USA (nationwide) and to the countries of : Belgium, Canada, Germany, Israel, Japan, the Republic of Korea, the Netherlands, and the United Kingdom. There was no military or government distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GIM